Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma...

Date First Received: November 21, 2007

Last Updated: June 17, 2008

Verified by: Hospital Authority, Hong Kong, June 2008

Clinical Trial Phase: N/A | Start Date: July 1999

Overall Status: Terminated

Estimated Enrollment: 465

Brief Summary

Official Title: “Prospective Randomized Study on Therapeutic Gain Achieved By Chemoradiation And/Or Accelerated Radiation For T3-4N0-1M0 Nasopharyngeal Carcinoma”

To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

  • Procedure: Conventional RT
  • Procedure: Accelerated RT
  • Drug: Cisplatin
  • Drug: 5-fluorouracil

Outcome Measures for this Clinical Trial

Primary Measures

  • Failure free survival rate
    • Time Frame: 5-year

Secondary Measures

  • Overall survival rate
    • Time Frame: 5-year
  • Disease-specific survival rate
    • Time Frame: 5-year
  • Complication-free rates
    • Time Frame: 5-year

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Undifferentiated or non-keratinizing carcinoma
  • Tumor staged as T3-4 AND N0-1
  • No evidence of distant metastasis (M0)
  • Performance status: 0-2
  • Marrow: WBC >= 4 and platelet = 100
  • Renal: creatinine clearance = 60
  • Informed consent

Exclusion Criteria:

  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Age >= 70
  • Palliative intent or tumor extent mandating AP opposing facio-cervical fields
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
  • Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
  • Previous chemotherapy
  • Patient is pregnant or lactating

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 70 Years

Clinical Trial Sponsor Information

Lead Sponsor: Hospital Authority, Hong Kong

Overall Clinical Trial Officials and Contacts

Anne WM Lee, Dr Principal Investigator Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital  

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00563862

Study ID Number: L/M-78 to PYH 08/79

ClinicalTrials.gov Identifier: NCT00563862

Health Authority: Hong Kong: Ethics Committee

HAREC Clinical Trial Registry

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